NEW YORK – German diagnostic firm SphingoTec announced on Tuesday that its Sphingotest PenKid assay has received its In Vitro Diagnostic Regulation (IVDR) certificate.
The certificate, awarded by notified body TÜV SÜD Product Service, indicates the test meets the requirements of new regulations that started going into effect in the EU a year ago.
The Sphingotest PenKid assay measures proenkephalin A 119-159, a biomarker that helps assess kidney function in critical diseases, in plasma and is intended to aid in the diagnosis of kidney injury in patients with sepsis or septic shock, SphingoTec said in a statement. The immunoluminometric test also has CE-IVD marking, the company noted.
"Ensuring compliance in all aspects of our clinical biomarker validation processes is an absolute requirement for our company and our licensing partners," SphingoTec Managing Director and CFO Angelo Moesslang said in a statement. "This includes robust quality management, setting up and maintaining technical documentation, continuous biomarker evaluation, and diligent manufacturing of products."
The Hennigsdorf, Germany-based firm's biomarker portfolio also includes bioactive adrenomedullin 1-52, which helps determine endothelial function in conditions like sepsis.